BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGER MOXA -YOUNG SHIN HEALTH

    MDR report key: 1604016 · Received January 14, 2010

    Report

    Report Number
    MW5014738
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    January 9, 2010
    Report Date
    January 14, 2010
    Manufacturer
    YOUNG SHIN HEALTH, LLC
    Product Code
    MVV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE TIGER MOXA CAUTERER IS EXTREMELY DANGEROUS. IT SAID THAT IT SHOULD NOT CONTACT THE SKIN DIRECTLY, HOWEVER, IT IS REAL HOT AND BURNED SKIN. THE MOXA ASH CAN BE DROPPED AND CAUSE FIRE. ALSO, KIT INCLUDES LANCET WHICH SEEMED LIKE IT'S NOT FDA APPROVED. I THOUGHT THAT FDA APPROVED ACUPUNCTURE AND ORIENTAL MEDICAL DEVICES. APPARENTLY, IT IS NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIGER MOXA -YOUNG SHIN HEALTH TIGER MOXA MVV YOUNG SHIN HEALTH, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other